Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial

Abstract Objective To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. Design Pragmatic, cluster randomised trial. Setting 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. Participants All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. Interventions Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. Main outcome measures The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. Results Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. Conclusions Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. Trial registration ClinicalTrials.gov NCT02485678 .

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Can Chemotherapy-Related Acute Care Visits Be Accurately Identified in Administrative Data?

Journal of Oncology Practice ◽

10.1200/jop.2017.023697 ◽

2018 ◽

Vol 14 (1) ◽

pp. e51-e58 ◽

Cited By ~ 4

Author(s):

Monika K. Krzyzanowska ◽

Katherine Enright ◽

Rahim Moineddin ◽

Lingsong Yun ◽

Melanie Powis ◽

...

Keyword(s):

Breast Cancer ◽

Emergency Department ◽

Adjuvant Chemotherapy ◽

Acute Care ◽

Administrative Data ◽

Validation Cohort ◽

Early Stage ◽

Early Stage Breast Cancer ◽

Algorithm Validation ◽

Ed Visits

Purpose: There is increasing interest in using administrative data to examine treatment-related complications that lead to emergency department (ED) visits or hospitalizations (H). The purpose of this study was to evaluate the reliability of billing codes for identifying chemotherapy-related acute care visits (CRVs) among women with early-stage breast cancer. Materials and Methods: The cohort was identified by using deterministically linked health databases and consisted of women who were diagnosed with early-stage breast cancer who started adjuvant chemotherapy between 2007 and 2009 in Ontario, Canada. A random sample of 496 patient cases was chosen as the validation cohort. Sensitivity (SN) and specificity (SP) were calculated for three scenarios: chemotherapy-related ED visit, chemotherapy-related H, and febrile neutropenia (FN)–related visit. For FN-related visits, three definitions were considered: general, moderate, and strict. Results: The administrative cohort consisted of 8,359 patients, 43.4% of whom had at least one ED or H, including 1,496 women who had multiple visits that resulted in 6,293 unique visits. Of these, 73.1% were considered CRVs. The algorithm performed well in identifying CRVs that included H either from ED (SN, 90%; SP, 100%) or directly from home (SN, 91%; SP, 93%), but less well for ED visits that did not result in H (SN, 65%; SP, 80%). Depending on which FN algorithm was used, 4.8% to 24% of visits were considered related. The moderate FN algorithm provided the best tradeoff between SN (69% to 97%) and SP (83% to 98%). Conclusion: Administrative data can be valuable in evaluating chemotherapy-related serious events. Algorithm validation in other cohorts is needed.

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Patient-reported health problems and healthcare use after treatment for early-stage breast cancer

The Breast ◽

10.1016/j.breast.2019.03.010 ◽

2019 ◽

Vol 46 ◽

pp. 4-11 ◽

Cited By ~ 8

Author(s):

K.M. de Ligt ◽

M. Heins ◽

J. Verloop ◽

C.H. Smorenburg ◽

J.C. Korevaar ◽

...

Keyword(s):

Breast Cancer ◽

Early Stage ◽

Health Problems ◽

Early Stage Breast Cancer ◽

Healthcare Use ◽

Patient Reported ◽

Reported Health

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National randomised trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer

http://isrctn.org/> ◽

10.1186/isrctn29941643 ◽

2012 ◽

Author(s):

Lisa Lloyd

Keyword(s):

Breast Cancer ◽

Hormone Replacement Therapy ◽

Replacement Therapy ◽

Early Stage ◽

Hormone Replacement ◽

Randomised Trial ◽

Early Stage Breast Cancer ◽

History Of

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132 poster A phase II randomised trial of partial breast irradiation for early stage breast cancer using the mammosite® radiation therapy system vs. conventional external beam radiotherapy (EBRT)

Radiotherapy and Oncology ◽

10.1016/s0167-8140(04)80183-x ◽

2004 ◽

Vol 71 ◽

pp. S65

Keyword(s):

Breast Cancer ◽

Radiation Therapy ◽

Phase Ii ◽

Early Stage ◽

External Beam Radiotherapy ◽

Randomised Trial ◽

Early Stage Breast Cancer ◽

Partial Breast Irradiation ◽

External Beam ◽

Breast Irradiation

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Randomised trial of two versus five years of adjuvant tamoxifen for postmenopausal early stage breast cancer: preliminary results of the SITAM-01

European Journal of Cancer ◽

10.1016/s0959-8049(01)81040-6 ◽

2001 ◽

Vol 37 ◽

pp. S150

Author(s):

M. Sacco ◽

M. Valentini ◽

M. Belfiglio ◽

A. Nicolucci ◽

F. Pellegrini

Keyword(s):

Breast Cancer ◽

Early Stage ◽

Randomised Trial ◽

Early Stage Breast Cancer ◽

Adjuvant Tamoxifen ◽

Preliminary Results

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Changes in adjuvant endocrine therapy over one year among postmenopausal women with early-stage breast cancer initiating aromatase inhibitors.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.34_suppl.11 ◽

2012 ◽

Vol 30 (34_suppl) ◽

pp. 11-11

Author(s):

Danielle Lindsay LaMorte ◽

Katherine E. Hartmann ◽

Vandana Gupta Abramson ◽

Ingrid A. Mayer ◽

Nancy Walker Peacock ◽

...

Keyword(s):

Breast Cancer ◽

Postmenopausal Women ◽

Endocrine Therapy ◽

Aromatase Inhibitors ◽

Clinical Decision Making ◽

Early Stage ◽

Adjuvant Endocrine Therapy ◽

Early Stage Breast Cancer ◽

Patient Reported ◽

One Year

11 Background: Aromatase inhibitors (AIs) are standard of care for adjuvant endocrine therapy (AET) to prevent recurrence of early stage breast cancer in postmenopausal women. Previous AET adherence research has focused on the 25-96% adherence observed with, but more information is needed about AI adherence, especially regarding the role of arthralgia (joint pain or stiffness) in AET changes. Our objective was to understand AET changes within a year of AI initiation. Methods: We examined AET switching (either to another AI or to tamoxifen), overall changes in AET (including switching and temporary or permanent discontinuation), and physician- and patient-reported arthralgia, using data abstracted from medical records and self-administered surveys among 93 patients initiating AI. We conducted Chi-square and Wilcoxon univariate analyses. Results: Anastrazole was initially prescribed to 64 patients (69%), letrozole to 28 patients (30%), and exemestane to 1 patient. A year after AI initiation, 64 patients (69%) had no change in AET. Among the 29 patients (31%) who had an AET change, 14 switched to at least one other AI, 11 switched to tamoxifen, 9 temporarily discontinued AET, and 7 entirely discontinued AET (categories not mutually exclusive). Average time to first AET switch was 182.7 days. Average number of AET switches was 1.4. Arthralgia was the most common reason for AET changes, noted in the records of 19 patients (66% of those who changed AET). Patients who changed AET reported more severe arthralgia (median pain from 0-10 among 8 joint groups =1.4, interquartile range [IQR]=0.3-2.6) at week 12 than those who did not (median=0.3, IQR=0-1.1), p=0.03. A higher proportion (46%) of the 28 patients who initiated with letrozole changed AET due to arthralgia, compared with 20% of the 64 patients who initiated with anastrazole (p=0.01). Conclusions: A substantial proportion of women initiating AI change AET over one year. Arthralgia appears to play a key role in AET changes, particularly for letrozole as compared with anastrazole. More longitudinal patient-reported arthralgia data are needed to guide clinical decision making about AI initiation and AET changes.

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Pain sensitivity and aromatase inhibitor (AI)-associated arthralgias (AIAA).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.9615 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 9615-9615

Author(s):

Norah Lynn Henry ◽

Steven Harte ◽

Anna S.C. Conlon ◽

Kent A. Griffith ◽

Gabriela Ramirez ◽

...

Keyword(s):

Breast Cancer ◽

Pain Sensitivity ◽

Pain Threshold ◽

Early Stage ◽

Pressure Pain Threshold ◽

Early Stage Breast Cancer ◽

Serum Estradiol ◽

Estrogen Deprivation ◽

Pressure Pain ◽

Patient Reported

9615 Background: AIAA affect up to half of AI-treated women with early stage breast cancer, and can lead to treatment discontinuation in 20-30%. The etiology is thought to be related to estrogen deprivation although the mechanism is unknown. In premenopausal women, lower estrogen levels have been associated with increased pain. Impaired descending pain inhibitory pathways, which may be a risk factor for developing chronic pain, have also been associated with lower estrogen levels. We prospectively tested whether AI-induced estrogen deprivation alters pain sensitivity, thereby increasing the risk of developing AIAA. Methods: Fifty postmenopausal women with early stage breast cancer initiating AI therapy were enrolled to the study. Subjects underwent experimental pressure pain testing and conditioned pain modulation (CPM) assessment and completed symptom questionnaires prior to AI initiation and after 3 months. Positive CPM values (>0) signify impaired descending pain inhibition. Serum estradiol concentrations were determined using an ultrasensitive assay. T-tests, Fisher’s exact test, and linear regression models were used to assess associations among baseline (BL) experimental pain measures, patient-reported pain, and clinical factors. P values <0.05 were considered statistically significant. Results: All subjects had decreased serum estradiol concentrations with AI therapy. No statistically significant change in pressure pain threshold or CPM with AI therapy was detected. In addition, no association between change in patient-reported pain with AI therapy and change in pain threshold or CPM was identified. Patients demonstrated impaired CPM at baseline (mean 8.0, SD 14.9), and this impairment was greater in patients previously treated with chemotherapy 14.4 vs 2.0, p=0.006), with non-significant trends towards this being more pronounced in those with more severe pain. Conclusions: AI therapy did not impact pressure pain threshold or CPM, suggesting that AIAA is not likely due to pain amplification from estrogen depletion. Studies examining chemotherapy-induced changes in pain processing are needed to better understand how these alterations might contribute to the pain that these patients often develop.

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